Event Description A physician reported to an international distributor that a patient experienced dyspnea and syncope. The physician was advised to reprogram vns settings but it is unknown if he did so or if he took any other form of intervention. Attempts for additional relevant information have been unsuccessful to date.

Event Description Updated information from the physician clarified that the patient experienced one brief episode of throat pain with vns stimulation which lead dyspnea. No intervention was necessary and the event has not recurred. The physician also clarified that the syncope was related to the patient's typical seizure activity and not an independent event of syncope. The physician stated that the seizure activity was not related to vns and the patient's seizure frequency has not increased. Vns function was deemed to be normal at all times with normal lead impedance observed.

Model Number 303-20Device Problems Circuit Failure; Loss of Power Event Date 09/07/2015Event Type Malfunction Event Description It was reported that a vns patient had pain in the neck and throat, and swollen spot in the neck. It was reported that short circuit was suspected, as the dcdc value dropped from 6 to 5, to 3, to 2 and now 0. The generator was switched off. It was reported that the x-rays will be taken then sent to the manufacturer for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that both lead and generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

Event Description It was later reported that the vns patient had eating disorder, hoarseness, dysphagia and protrusion. Review of the available programming and diagnostic history received from the nurse showed normal diagnostic results through (b)(6) 2012. The x-rays were taken and sent to the manufacturer for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin seems to be fully inserted into the generator connector block. The electrodes placement seems to be normal. One tie-down, strain relief bend were used to secure the implanted lead but not as indicated in the labeling. Part of the lead was behind the generator. No lead breaks or sharpe angles were visible on the assessed lead parts.

Event Description Further information received indicating that the patient underwent a full revision. The lead was replaced due to lead function issue (low impedance) and the generator was replaced likely due to battery depletion. No explanted devices return is expected at ths time.

Model Number 103Device Problems Generator; Loss of or Failure to Bond; Migration or Expulsion of Device ; Material Protrusion / Extrusion; Lead Event Date 04/07/2015Event Type Injury Event Description It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.

Event Description It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

Event Description It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out". Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015. Additional information was received that the patient did not believe the surgeon properly closed the incision. Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up. Patient has also reported difficulty eating and chewing and states that she has lost weight since implant. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

Event Description Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays. The device had still not been turned on as of (b)(6) 2015. No additional relevant information has been obtained to date.

Model Number 302-20Device Problem High impedance Event Date 10/22/2015Event Type Malfunction Event Description It was reported by a physician that a patient's vns showed high lead impedance on diagnostics at a clinic visit. Additional relevant information has not been received to-date. No known surgical intervention has occurred to-date.

Event Description Follow-up to the physician revealed a chest x-ray was taken and showed that the device migrated down near the left breast and medial to the original location. The x-rays were not sent to the manufacturer for review. The patient reported the migration had occurred over the past three years. The patient reported pain due to the migration which was explained by the physician as mechanical from the patient's bra rubbing on the unit. The last systems diagnostics in (b)(6) 2015 were reportedly fine. The physician did not know whether the sutures were non-absorbable or the relationship of the sutures to the migration. It was reported the patient has not had any significant changes in weight. The physician believes that the high impedance and the migration are related and that the high impedance is the result of the migration of the generator. The device was not turned off, and the settings were not changed.

Event Description Operative notes for the implant surgery were received and indicated that a stitch was used to secure the generator, but the type of suture was not indicated. For the lead, two loops were formed and were stated to be secured with stitches. The type of suture used to secure the loops of the lead was not indicated.

Event Description Clinic notes from a visit on (b)(6) 2016 were received providing that the patient had her generator disabled on (b)(6) 2016 due to discomfort, however she experienced an increase in frequency and more violent seizures since it was turned off. The patient had the device turned back on (b)(6) 2016. Diagnostics on (b)(6) 2016 showed high lead impedance. Follow-up to the physician revealed that the additional discomfort was experienced in the neck due to stimulation and resolved after the device was turned off. The pain at the chest was specified to be in the left superior chest and did not resolve after the device was turned off. Re-enabling the device did not resolve the increase in seizures.

Event Description An implant card was received 05/24/2016 indicating the generator was replaced prophylactically and the lead was replaced due to lead discontinuity. The explanted devices were reported to have been discarded and are unable to be returned for analysis.

Model Number 304-20Device Problem Insufficient Information Event Date 07/13/2015Event Type Injury Event Description On (b)(6) 2015 the patient reported that her voice alteration, which she stated is not related to vns stimulation, has progressed since surgery to the point where she believes she has, at a minimum, partial vocal cord paralysis. The patient noted she also has severe pain when trying to speak. It was previously reported on (b)(6) 2015 that the patient experienced voice alteration and dyspnea following implant surgery on (b)(6) 2015. The patient went to the emergency room and received anti-inflammatories and albuterol. The issues resolved, and it is planned to turn on the vns on (b)(6) 2015. The patient later reported that she still has not yet gotten her voice back and since receiving vns she has been experiencing nausea while eating and it feels like there is "air in her chest". Good faith attempts for further information were unsuccessful.

Manufacturer Narrative (b)(4). Corrected data: inadvertently did not include the suspect device udi on the initial report.

Model Number 105Device Problem Adverse Event Without Identified Device or Use Problem Event Date 10/02/2013Event Type Injury Event Description Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description Follow-up revealed that the painful stimulation was occurring in the left neck.

Event Description Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

Event Description It was reported that the patient was complaining of swelling and tenderness around the generator site. The swelling and pain was believed to be due to some scar tissue that had developed since implant that caused severe pain and irritation when the patient moved her arm. The patient underwent a generator pocket revision surgery on (b)(6) 2015 and a hematoma was identified at the generator site. It was reported that this was caused by the patient doing some lifting too soon after vns implant surgery. No migration had occurred. The hematoma was drained and the generator was re-sutured in place. Diagnostics following the revision were within normal limits. No additional relevant information has been received to date.

Event Description The patient was seen in follow-up with the surgeon and it was noted that there was still swelling in the neck area. The surgeon ordered a laser treatment, but is certain he will need to proceed with another surgery. No additional surgical interventions have been performed to date.

Event Description It was reported that the patient was seen by an ent who performed a laser procedure. It was found that there is a gland that is leaking and a procedure will need to be performed. No additional relevant information has been received to date.

Model Number 302-20Device Problem High impedance Event Date 09/03/2015Event Type Malfunction Event Description It was reported that high impedance was observed on vns patient's system. It was reported that the patient, who had good seizure control with the vns, experienced an increase in seizures and pain around his voice box. The patient was seen to the clinic on (b)(6) 2015 where his device was interrogated and showed high lead impedance. It was reported that the device was switched off. X-rays were taken but no obvious lead break was seen. Those x-rays were not sent to the manufacturer for review. It was reported that the device was again interrogated on (b)(6) 2015 and high impedance results persisted (>=10000 ohms). The device was then left switched off. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. No known surgical interventions have been performed to date.

Event Description Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. The suspect lead was explanted and a replacement lead was implanted. No additional relevant information was provided to date.

Event Description Further information was received from a nurse indicating that the explanted lead was discarded by the facility. Therefore, analysis cannot be performed.

Event Description It was reported that the patient had her vns explanted on (b)(6) 2015 due to an unknown reason. The physician later reported that the reason for explant was that the device was shocking her although it was off and battery out. That it was uncomfortable for the patient and she didn't like that she could see the wire over her clavicle. It is unknown when and where the patient's generator had been implanted as the patient had previously been explanted in 2014 and has obviously since been re-implanted but it is unknown when. It was later reported that the lead was explanted on (b)(6) 2015 due to pain and that the patient's generator was explanted on (b)(6) 2014 due to pain when moving her left arm. She stated the electrodes were left on the nerve and the remaining lead body. It was also reported that the patient's device was explanted due to lack of efficacy. Good faith attempts for further information from the physician have been unsuccessful. The explanted lead was returned for product analysis on 11/03/2015. The generator has not been returned to date.

Event Description The physician's office reported that they only saw the patient to turn off her vns, that they were not the patient's primary neurologist. Good faith attempts were made for further information from the primary neurologist but no further information was received. Product analysis was completed on the lead. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

Model Number 102Device Problem Adverse Event Without Identified Device or Use Problem Event Date 10/01/2015Event Type Injury Event Description Initially, it was reported that the patient was scheduled for device explant. The patient's neurosurgeon reported that the explant occurred because the device hasn't worked in 8 years and was painful. The patient underwent explant. No additional relevant information has been received to date. The explanted device has not been received for analysis to date.

Event Description The explanting facility does not return explanted devices for analysis; therefore, no analysis can be performed. The physician reported that the patient was at the generator site and was programmed off 8 years prior due to lack of efficacy. The pain was not associated with device stimulation and the surgery was taken for patient comfort.

Event Description It was reported the patient was hospitalized for a respiratory condition. During the patient's stay in the hospital, the pulmonologist told her that if the vns was removed, she would breathe better. However, the neurosurgeon and the epileptologist stated they disagreed with the pulmonologist and do not believe the patient's respiratory issue was related to vns. It is unknown why the neurosurgeon and the epileptologist believe the respiratory issue is not related to vns. The patient's vns was programmed off on (b)(6) 2015 and the patient will have a follow up appointment for an additional assessment. Attempts for additional information have been unsuccessful to date.

Event Description Additional information was later received on (b)(6) 2016 that the patient was seen recently. Her vns is still off, and her seizures have increased. The patient has a scheduled emu stay for two weeks to assess her epilepsy. Per the neurologist, no further action will be taken with her until after the emu stay and recommendations are received. The patient as agreed to turn the vns back on if it is recommended. No additional relevant information has been received to date.

Event Description The patient was seen by neurosurgery for patient request to have vns removed. The patient reported the device had been off and vns causes her pain and affects her breathing. The patient also needs a mri of the spine. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description It was reported that a vns patient underwent generator prophylactic replacement surgery, on (b)(6) 2015. During the replacement, high impedance was observed when the new generator was connected to the existing lead. The system diagnostic tests were performed prior to the surgery and the results were normal (dcdc 2). When the new generator was connected, diagnostic tests were performed and the dcdc was 7. A pin insertion issue or a generator issue were ruled out by performing several attempts; high impedance persisted. It was then decided to move forward with replacing the lead. It was reported that apparently patient had complained of neck pain in weeks leading up to surgery. The return of the explanted devices is expected but they have not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Event Description Further information was received indicating that the full replacement surgery took place on (b)(6) 2015, not on (b)(6) 2015 as previously reported. The explanted devices were returned to the manufacturer on (b)(6) 2016 for analysis. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis on the returned lead portions did not confirm the reported allegations. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations. Note that since portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Model Number 105Device Problems Migration or Expulsion of Device ; Malposition of device Event Date 09/04/2015Event Type Injury Event Description It was reported that the patient was experiencing migration of the generator. The patient reported that the migration of her vns generator was due to body architecture changes. The patient had recently lost a lot of weight (not alleged to be related to vns) and when the patient would move on her side or her back while lying down she felt the generator "flip" in the pocket to where it was angled at a 45 degree angle at times. She stated the sensation was uncomfortable and painful. Additional information was received that the patient was considering pocket revision surgery. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

Event Description It was further reported the patient will be having surgery for patient comfort and generator movement. The physician is unsure what is causing the patient's pain but noted she had intentionally lost a significant amount of weight and she was implanted with a m105 generator, from an m103 generator, in (b)(6) 2014. The physician explained the patient did not have the pain when implanted with the m103 generator. No known surgical interventions have occurred to date. No additional relevant information have been received to date.

Model Number MODEL 250Device Problems Use of Incorrect Control Settings; Failure of Device to Self-Test Event Date 10/22/2015Event Type Malfunction Event Description It was reported that the vns patient's device was tested recently and the patient began coughing and gagging due to device stimulation delivered from the diagnostic test. The patient's device had previously been disabled and believed to have remained programmed off following the office visit. Additional information was received stating that the patient's device was evaluated by another physician on (b)(6) 2015 as the patient had been experiencing left jaw pain and the device was found to be programmed on. It is possible that an interrupted system diagnostic test occurred during the previous office visit that caused an unintended change in device settings. Attempts for additional relevant information have been unsuccessful to date.

Event Description Additional programming and diagnostic history was received which showed that an interrupted system diagnostic test occurred at the end of the office visit on (b)(6) 2015 which likely caused the unintentional device enablement. A final interrogation was not performed. An interrogation prior to the interrupted test confirmed that the device was disabled.

Model Number 106Device Problem Insufficient Information Event Date 11/02/2015Event Type Injury Event Description It was reported that a patient, recently implanted with vns system, had pain and hoarseness. The patient was stating that it was tight and hurting a lot. It was reported that the patient was seen by a nurse and her physician, where she received antibiotics because the incision looked red. But the patient's throat was sore and her voice was still hoarse. It was reported by the nurse that the device had not been turned on yet, so the pain and soreness was likely a result of the surgery. Further information received indicates that the patient was again seen in clinic and she was doing well; the pain has stopped and her wound was dry. The patient's voice has been settled. It was reported that the device is now turned on. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

Model Number 304-20Device Problems Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem Event Date 11/06/2015Event Type Injury Event Description It was reported that a vns patient was referred for revision surgery as the patient is experiencing discomfort in the neck area near the electrodes after the patient lifted her son. The physician stated that the device was working fine, but has turned the device off. No known surgical intervention has occurred to-date. No additional information has been received to-date.

Event Description Follow-up to the physician's office revealed that the pain in the neck first occurred on (b)(6) 2015 and the patient's device was disabled on the same day. The patient's vns was first reduced to the lowest settings and eventually shutoff. The patient was referred to the surgeon. X-rays were reported to have been taken, however the x-rays have not been received by the manufacturer for review.

Manufacturer Narrative Corrected data, event description: it was inadvertently reported that x-rays had been taken, when x-rays had been ordered, but have not been known to be performed to-date.

Event Description X-rays were ordered by the physician, but are not known to have been performed to-date.

Model Number 303-20Device Problem High impedance Event Date 12/23/2015Event Type Malfunction Event Description It was reported that a patient, who was recently implanted with vns, experienced discomfort when the device was initially programmed on. Diagnostics showed that high impedance was present. The physician programmed the patient's generator off and ordered x-rays. The physician's office evaluated the chest x-rays that were taken on (b)(6) 2015, and they did not see anything that looked wrong. The x-rays were not available for livanova to evaluate. The patient had lead revision surgery on (b)(6) 2016. The surgeon did not test the lead impedance during surgery. He did not test the connection of the existing lead to the generator prior to replacing it. Therefore, it cannot be determined if there was incomplete lead pin insertion. The explanted lead is expected for return, but it has not been received to date.

Event Description The patient felt pain in the left neck when her vns was turned on. The explanted lead was received on 02/02/2016. Analysis has not been completed to date.

Event Description Analysis was completed on 03/01/2016. The entire lead was evaluated. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The high impedance was most likely related to a lead pin insertion issue since the lead did not have any anomalies that would have caused the high impedance. Since the pain the patient felt was in the neck area, it would not have been related to the high impedance, which only would have caused painful stimulation at the generator site.

Event Description It was reported that a patient experienced neck and jaw painful stimulation that started in (b)(6) 2015. The physician did not believe that the pain in the neck and jaw were consistent with vns stimulation. The patient had an mri, which did not show a lead fracture, according to the physician. However, the patient then started complaining of shooting pain periodically throughout the day. The physician decided that the patient would have revision surgery. Attempts for further information were unsuccessful, and no surgical intervention has occurred to date.

Event Description Further information was received indicating that the patient felt the shooting pain in his neck, and the surgery was being done for patient comfort only. The patient had generator replacement surgery on (b)(6) 2016. The explanted generator is expected for return, but it has not been received to date.

Event Description Analysis of the generator was completed on 03/08/2016. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator was at an ifi = no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description It was reported on (b)(6) 2016 from the patient that she has had a recent onset of a shocking sensation with her vns stimulation. The patient reports that she visited the er and the vns was interrogated. The patient reports that interrogation revealed an issue, but the patient was unclear on what the issue was. The patient stated that the reason she was at the hospital was to visit her sister and then she could not feel the stimulator going off. She states that she usually feels it but on sunday (b)(6) 2016 she did not feel it. She was worried so she went down to the er to ask if they had a doctor on staff that could come down to check her vns to make sure it was working. She also mentioned that she feels shocking sensations similar to the feeling of "putting your tongue on a 9v battery. " she has been experiencing this on and off for about two weeks. The last time she experienced this sensation was (b)(6) 2016. The pain that she is feeling with stimulation is located in the neck area just above the incision. She states that she also feels the wire in the neck area. The patient requested to have her setting increased to 0. 50/20/250/30/5. 0 and she tolerated the new settings. The patient did state that she fell two weeks ago when she had a seizure. It is unknown what unusual thing was seen at the er visit since there was nothing out of the ordinary seen on (b)(6) 2016 visit. Attempts were made to the er to gather more information but have been unsuccessful to date.

Event Description Information was received from the er stating that: "we are unable to comply with your request at this time for the following reasons: we show no treatment at this facility for the dates of service you requested. ".

Event Description On (b)(6) 2016 it was reported that the patient no longer feels shocking sensation but does indicate an increase in pain in left side of neck near the wires. Initially the even of painful stimulation should not have reported since the diagnostics were within normal limits indicating that there was no device issue.

Model Number 103Event Date 07/19/2012Event Type Injury Event Description On (b)(6) 2015 it was reported that the patient¿s generator and a lead portion were explanted on (b)(6) 2013. The hospital reported that they do not return explanted devices, therefore the explanted products could not be returned for product analysis.

Event Description The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

Model Number 103Event Date 01/01/2015Event Type Injury Event Description It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.

Event Description Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Event Description Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

Event Description Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

Event Description On (b)(6) 2015 it was reported that every time the patient uses the magnet, she feels as though her vein is popping out of her neck. The patient says she had a fall in (b)(6) 2015 on her face and neck and since then when she uses the magnet, it feels like the vein in her neck is popping out. The patient thinks she damaged the lead. It was also noted that the discomfort in (b)(6) was not too bad but that it has returned the last few days. The patient was scheduled for lead replacement. The patient's vns was disabled on (b)(6) 2015. The patient's surgery was later rescheduled due to issues at the hospital. The patient now has a fever and has had two rounds of antibiotics. Although surgery is likely, it has not occurred to date.

Event Description On (b)(6) 2016, the patient was seen by the physician and system diagnostic test results were in normal range. The patient is still having a lead replacement; although surgery is likely, it has not occurred to date. The patient's discomfort was noted to be in the neck area and associated with magnet stimulation at 0. 5ma. The device was disabled. The pain started after her fall in august.

Event Description On (b)(6) 2016 it was reported that the patient underwent lead revision surgery. The explanted lead was discarded by the hospital and therefore cannot be returned for product analysis.

Model Number 302-20Device Problem Adverse Event Without Identified Device or Use Problem Event Date 08/26/2015Event Type Injury Event Description It was reported the patient feels pain upon sneezing. The patient's vns settings were decreased which decreased the pain; however, the surgeon is still planning a lead replacement as he feels the pain may be related to fibrosis along the lead as the pain is positional no surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description An implant card was received by the manufacturer which showed the patient had a prophylactic generator replacement on (b)(6) 2015. The surgeon did not want to replace the lead as the impedance value was within normal limits. It was reported the patient's device was programmed back on and there was no complaint of pain. The surgeon has no plan to replace the lead and he is unsure what was causing the previously reported pain. The explanted generator was reported to be discarded at the hospital and is not expected to be returned to the manufacturer for analysis.

Event Description Additional information was received that the patient was still experiencing pain, and the patient requested to have the lead replaced. The lead replacement surgery occurred on (b)(6) 2016. The device was reportedly discarded following the surgery. No additional pertinent information has been received to date.

Event Description It was reported that the patient continued to experience the throat discomfort that she had experienced with the explanted lead. However, the discomfort reportedly improved with the lead replacement surgery.

Model Number 303-20Device Problem Appropriate Term/Code Not Available Event Date 12/01/2015Event Type Injury Event Description It was reported on (b)(6) 2015 that the patient was experiencing a painful, jolting sensation in her neck. The pain was constant. The device was turned down from 1. 75ma to 1. 25ma, but the patient reported that it was still painful. The date of onset of the pain was unknown. No known trauma had occurred. The physician performed diagnostics, and the impedance was within normal limits at 2800 ohms. It was reported on (b)(6) 2015 that the patient was referred for generator and lead replacement surgery with the device likely programmed to not delivery therapy until surgery. An implant card was later received reporting that the patient had lead replacement on (b)(6) 2015 due to pain at the lead site. The generator was not replaced. No additional relevant information has been received to date. The explanted lead has not been received by the manufacturer for analysis to date.

Event Description Additional information was received from the surgeon reporting that he was observed during lead replacement surgery that one of the helicals was off of the vagus nerve, so he believes this was causing the painful stimulation to the patient's muscles. There was no particular event that was known or believed to have contributed to the helical coming off the nerve, but he notes that she does have tonic-clonic seizures so it may have occurred from a seizure. The helical appeared to be pulled medially and pulled quite a bit. The device was turned off prior to surgery for the pain. He has not heard from the patient since surgery, so takes that as a good sign that her pain has improved/resolved. No further information was provided. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.

Event Description Analysis of the lead was also completed. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Note that since the (-) green electrode was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

Model Number 105Device Problem Adverse Event Without Identified Device or Use Problem Event Date 09/21/2015Event Type Injury Event Description It was reported that a patient experienced coughing, pain and, gagging when the magnet was swiped at the higher setting. The patient was reported to tolerate normal mode settings. The device was turned off as the physician thought there might have been a lead issue. The last systems diagnostics were on (b)(6) 2015 and were within normal limits. Follow-up by the company representative revealed that the patient first reported the symptoms on (b)(6) 2015 and later tolerated all settings on (b)(6) 2015. On (b)(6) 2015 she tolerated normal mode, but not the magnet mode. X-rays were taken and it was stated that the physician did not see any issues in the x-rays. The x-rays have not been received by the manufacturer for review to-date. Additional follow-up by the company representative to the physician revealed that the patient had a laryngoscopy in the summer of 2015, and the neurologist believed the procedure may have disrupted the lead, and caused the patient's symptoms. The issues were reported to have resolved after turning off the device. The company representative reviewed diagnostics from the physician's handheld and the results were reported to be normal. The patient scheduled an appointment with the surgeon and had the lead and generator replaced (b)(6) 2015. The generator was reported to have been replaced prophylactically along with the lead and no issues were suspected with the generator. The choice by the patient to request revision of the device was stated to be due to the pain and discomfort. Additional follow-up to the physician's office revealed the lead was decided to be replaced from a visit with their office at the beginning of (b)(6). It was reported by the staff that the surgery was due to malfunction of the lead wire, but additional information regarding the malfunction was not provided. It was reported that diagnostics were not recorded in the notes from the patient's next visit before the surgery. No additional relevant information has been received to-date. The explanted devices have not been received for analysis to-date.

Event Description It was reported that the explanted products were discarded by the surgical facility.

Event Description It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet. The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use. Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching. No settings were changed due to the reported muscle twitching.

Event Description The patient underwent vns explant surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted products.

Event Description Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted. It was stated that she developed issues with tension at the neck when trying to do sit-ups. When the vns activated, she experienced contractions of the laryngeal musculature. The patient reported twitching in her neck muscles with magnet stimulation. The vns magnet mode was programmed off. It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before. The operative notes from the initial implant were included and no complications were reported. It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.

Event Description Notes dated (b)(6) 2016 state that the patient's battery is reported to be near end of service and requires replacement. Notes dated (b)(6) 2016 state that one week prior the patient had onset of shooting pain in her left axilla. The notes state that the patient was seen urgently by the neurosurgeon upon complaints of pain/discomfort of concern for vns malfunctioning. Noted to have protruding piece of chest wall tissue of concern for a surgical clip vs wire/generator attachment. Vns was interrogated and found to have normal impedance. Chest wall protrusion of concern for adhesions that may be contributing to muscular skeletal discomfort. The vns was turned off for 20-30 minutes and then turned back on, patient was observed during this time for side effects/adverse effects and no discomfort was noted. It was indicated that on (b)(6) 2016 the patient had surgery. The generator was not changed but it was indicated that something was done to the leads although it is not clear at this time what they did. Post-op impedance was still within normal limits.

Manufacturer Narrative Information received the day the initial mdr was submitted was inadvertently omitted from the initial mdr.

Event Description The patient was set to have surgery but it was determined that no replacement of the generator was necessary. The leads were manipulated and it was stated that the device seems to be ok. Clarification from the nurse was obtained which showed that the reason for the planned replacement was solely for the patient's neck pain. There was no chest pain, only pain in the neck area of the vns. She confirmed the battery was still good and impedance levels were fine. The surgeon also took some x-rays and determined the positioning of the tie-down (or what they called the elastic flange) was likely causing her discomfort against the skin. She stated that they dissected the flange out and because there was enough scarring around the lead they did not need to secure it again. The procedure was for patient comfort.

Model Number 102Device Problem Device Operates Differently Than Expected Event Date 11/01/2015Event Type Injury Event Description It was reported that the vns patient has had adverse events ever since she was implanted. It was reported that patient has had earache and inflamed tonsils, especially on the left side, as well as terrible lethargy. It was reported that the device output current was gradually increased but the patient then complained of severe earache and pain in her tonsil, the output current was then decreased to 0. 50ma which relieved patient's pain tremendously. It was reported that the patient was treated for tonsillitis with earache, which treatment was inefficacious. Patient is planned for a week long in hospital tests at the beginning of march 2016. Additional information was received that patient has had episode of tonsillitis before vns implant, but not tinnitus. The pain started when the stimulation was switched on. The earache occurs when the device stimulates and continues. The patient was treated for tonsillitis because the tonsil was inflamed, but it was not necessarily diagnosed as tonsillitis. When the stimulation was switched on, the doctor could actually see it affecting the tonsil on the left. It was reported that device diagnostic test gave normal results.